US Food and Drug Administration (FDA) has issued a complete response letter to Bristol-Myers Squibb Company regarding the Biologics License Application for belatacept in kidney transplantation.
While no new clinical studies have been requested, the complete response letter requests the 36-month data from the ongoing phase-3 studies to further evaluate the long-term effect of belatacept. The company will work with the US FDA to provide the data as soon as they are available. The Biologics License Application submitted for belatacept included 24-month data from the phase-3 studies.
Other requests raised in the letter primarily relate to information to support the manufacturing of belatacept and the proposed risk evaluation and mitigation strategy (REMS).
“Bristol-Myers Squibb is committed to belatacept as a potential new therapeutic option for kidney transplant patients,” said Brian Daniels, senior vice president, Global Development and Medical Affairs, Bristol-Myers Squibb. “We will continue to work closely with the US FDA to address their questions.”
The Biologics License Application for belatacept was accepted for filing and review by the US FDA in September 2009. An US FDA Advisory Committee panel met on March 1 of this year and voted 13 to five to recommend the approval of belatacept for the prophylaxis of rejection in kidney transplant recipients. The US FDA is not bound by the recommendations of its Advisory Committee, but takes its advice into consideration when reviewing new drug applications.
Belatacept is an investigational agent under development by Bristol-Myers Squibb for the prophylaxis of organ rejection in adult patients receiving kidney transplants.
Bristol-Myers Squibb is a global biopharmaceutical company committed to discovering, developing and delivering innovative medicines that help patients prevail over serious diseases.